PORT WASHINGTON, N.Y., July 29, 2019 /PRNewswire/ -- Allergan issued a worldwide recall of its BIOCELL textured breast implants and BIOCELL tissue expanders following reports of women being diagnosed with cancer, with some cases resulting in death. The company's recall followed an FDA Safety Alert and an FDA Recall Request.
Allergan, a medical device manufacturer, has recalled all of its BIOCELL textured breast implants and tissue expanders, removing the products from the market worldwide. The recall was announced after the United States Food and Drug Administration (FDA) reported a significant increase in the number of cases of women with Allegan's BIOCELL textured breast implants who have been diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma.
The affected BIOCELL textured breast implants and BIOCELL tissue connectors have already been recalled by three dozen countries worldwide. The FDA reports that there is now a total of 573 cases of BIA-ALCL worldwide in women who had Allergan BIOCELL textured breast implants, with 33 of these women dying from cancer. The FDA also states that women with Allergan BIOCELL textured breast implants are 6 times more likely to develop BIA-ALCL than with similar breast implants manufactured by other medical device companies in the United States.
Specific BIOCELL Textured Breast Implants and Tissue Connectors Subject to Recall
Allergan's recall of its BIOCELL textured breast implants includes the following products:
- Natrelle saline-filled breast implants;
- Natrelle silicone-filled breast implants;
- Natrelle Inspira silicone-filled breast implants; and
- Natrelle 410 Highly Cohesive Anatomically Shaped silicone-filled breast implants.
Allergan's recall of its BIOCELL tissue expanders includes the following products:
- Biocell Tissue Expanders:
- Natrelle 133 Plus Tissue Expander; and
- Natrelle 133 Tissue Expander with Suture Tabs.
All unused products will be removed from shelves. Women with any of the above-listed breast implants are instructed to see their doctor if they have any swelling or pain near the breast implant. Women are not instructed to have the breast implants removed if they do not have any symptoms.
Parker Waichman LLP is Offering a Free Legal Claim Review
Parker Waichman LLP is helping victims recover monetary compensation for lymphoma caused by Allergan's BIOCELL textured breast implants and tissue connectors. If you or a loved one are diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), call Parker Waichman LLP to hold Allergan responsible by filing a civil lawsuit. For more information, please contact attorney Jerrold S. Parker at Parker Waichman LLP through the firm's website YourLawyer.com or by calling 1-800-YOURLAWYER (1-800-968-7529).
SOURCE Parker Waichman LLP